When you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe.
Your work will have real-world impact, and you'll be supported in achieving your career goals.
**Location/Division Specific Information**
Ferentino, Italy
**How will you make an impact?
**
Ensure the Quality of the Technical Area Departments, dealing in particular with the management of Customer Audits and Regulatory Inspections, Deviations, CAPAs, Changes, SOPs, relating to Process Maintenance and Utilities, Calibrations and Equipment Qualification.
**What will you do?
**:
- Support the Quality Department in preparing, managing and actively participating in Customer Audits and Regulatory Inspections.
- Support the Technical Departments (Equipment Qualification and Maintenance) in increasing their Quality Culture, helping them with Deviations, CAPA, Change, SOP, Training, Risk assessment and Data Integrity.
- Analyze the historical data and results of the qualification and maintenance activities.
- Assure the protocols, reports and SOPs are in compliance with current regulations (current EU GMP, US GMP) and company quality standards.
- Participate in calls/meetings with customers to support the discussion on technical topics for their area of expertise.
- Collaborate with the Team Leader to identify and solve the quality gap of Technical Departments.
**How will you get here?
**
**Education**
Technical / Scientific Degree (Mechanical Engineering, Chemical Engineering, CTF, Biomedical Engineering, Pharmacy, Industrial Chemistry)
**Experience**:
- Experience in pharmaceutical industries
- At least 2 years' experience in Equipment Qualification
**Knowledge, Skills, Abilities**:
- Knowledge of the main pharmaceutical machines/systems
- Knowledge of GMP and national/international regulations and ISO 9001, ISO 19011, ISO 17021
- Fluent in English
- Good Team-worker
- Good problem-solving abilities
- Proficiency in Microsoft Office suite and electronic systems such as Documentum and Trackwise
- Be prepared to work with conflicting priorities, under time constraints and in a dynamic team environment
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell.
Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.